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SAREUM HOLDINGS PLC
(“Sareum” or “the Company”)
FINAL RESULTS FOR THE YEAR ENDED 30 JUNE 2021
Cambridge, UK, 25 October 2021 – Sareum Holdings plc (AIM: SAR), the specialist drug growth firm delivering focused small molecule therapeutics to enhance the remedy of autoimmune ailments and most cancers, broadcasts its audited outcomes for the yr ended 30 June 2021.
The Company might be holding a presentation to traders on Tuesday, 2 November 2021 at 11.00 a.m. through the Investor Meet Company platform – please click on on this hyperlink to register to attend:
https://www.investormeetcompany.com/sareum-holdings-plc/register-investor
The Company expects to publish its Annual Report and Accounts, together with the Notice of the Company’s Annual General Meeting, in November 2021.
OPERATIONAL HIGHLIGHTS (together with post-period updates)
Proprietary Programmes – Selective TYK2/JAK1 Inhibitors
SDC-1801 (autoimmune ailments and extreme Covid-19)
Progress made advancing SDC-1801 with preclinical part nearing completion
Development of improved drug product underway for first medical research; resolution made to develop probably higher-value capsule formulations relatively than orally dosed options or suspensions means this stage is anticipated to finish throughout H1 2022
Consultants appointed to help in growing the plan for preliminary medical research
Exploratory Clinical Trial Application (“CTA”) now anticipated to be filed mid-2022 owing to the extra time wanted to fabricate capsule drug product, and topic to profitable completion of ultimate toxicity and security research
First medical research focused to start shortly thereafter, topic to drug product provide, gaining the requisite approvals and extra funding
Promising mobile and in-vivo outcomes from accomplished UK Research & Innovation (“UKRI”) -funded analysis challenge recommend therapeutic potential of SDC-1801 in extreme part Covid-19
Encouraging preclinical information reported with Sareum’s TYK2/JAK1 inhibitors in systemic lupus erythematosus illness fashions – research performed by co-development accomplice SRI International beneath a US Department of Defense grant
SDC-1802 (most cancers immunotherapy)
Translational research underway to outline the optimum most cancers utility previous to finishing toxicology and manufacturing research
Two new US patents granted (January and September 2021) strengthening patent safety, which is now in place throughout all main territories
Licensed Programmes
SRA737: A Selective Chk1 inhibitor (most cancers)
Sierra Oncology, Inc. (“Sierra”) continues to discover choices for persevering with growth and Sareum believes that the licensing settlement modification [noted below] will show vital in expediting this growth
In November 2020, Sierra and CRT Pioneer Fund LP (“CPF”) amended the 2016 licensing settlement for SRA737: revised milestone schedule contains $2.0m fee upon the dosing of the primary affected person within the subsequent medical trial, and barely lowered total excellent milestones payable by Sierra (lowered from $319.5m to $290.0m)
Sareum stays eligible to obtain 27.5% of the economics of the Licence Agreement
Post period-end, Sierra introduced the in-licensing of the BET inhibitor AZD5153 (now referred to as SRA515) from AstraZeneca and famous potential combos with SRA737 as a potential pipeline growth alternative and that first medical research might begin in H1 2022
FLT3+Aurora Inhibitors (haematological cancers)
Licensing accomplice for FLT3+Aurora kinase inhibitor programme discontinued growth because it was unable to realize required bioavailability and returned worldwide rights to Sareum; the programme stays out there for additional licensing while the Board considers various routes to progress the programme
AUDITED FINANCIAL HIGHLIGHTS
Raised £2.37m earlier than bills in June 2021 by way of two subscriptions by a excessive web value particular person
Cash at financial institution as of 30 June 2021 of £2.7m (£1.3m as at 31 December 2020; £1.8m as at 30 June 2020)
R&D tax credit score of £0.13m obtained in January 2021
Loss on unusual actions (after taxation) for the yr ended 30 June 2021 of £1.5m (2020: lack of £0.99m), reflecting the elevated R&D expenditure required for preclinical growth
Post Period End
Raised an extra £2.18m (earlier than bills) in July and August 2021 by way of share subscriptions by two further excessive web value people plus an train of warrants.
Cash at financial institution as of 30 September 2021 of £4.4m
Full Year Results 2021 out there as PDF doc: FY Results 2021
Dr Tim Mitchell, CEO of Sareum, commented:
“Sareum continues to advance the preclinical growth of its proprietary twin TYK2/JAK1 inhibitor programmes. We are near finishing the preclinical growth of SDC-1801 with the intention of beginning the medical growth of this novel compound within the second half of 2022. This is clearly a vital milestone for the Company. In addition, the early preclinical outcomes now we have seen with SDC-1801 in our Covid-19 programme recommend that it could have potential to deal with the hyper-inflammatory response that some sufferers expertise, and we’re wanting on the subsequent steps to advance growth on this indication. We are significantly happy to have raised substantial further funding that might be deployed to advance these programmes into medical growth and construct a sturdy information package deal that may add momentum to our ongoing partnering actions for these thrilling and differentiated property.
“Furthermore, the chance that medical mixture research of SRA737 could possibly be initiated by Sierra within the first half of 2022 may be very encouraging and would symbolize a big advance within the growth of the SRA737 programme. We stay up for additional updates on the medical growth of this candidate because the programme progresses.”
The info contained inside this announcement is deemed by the Company to represent inside info beneath the Market Abuse Regulation (EU) No. 596/2014
For additional info, please contact:
Sareum Holdings plc
Tim Mitchell, CEO
01223 497 700
Strand Hanson Limited (Nominated Adviser)
James Dance / James Bellman
020 7409 3494
Hybridan LLP (Nominated Broker)
Claire Noyce
020 3764 2341
MEDiSTRAVA Consulting (Financial PR)
Mark Swallow / David Dible
020 7638 9571
About Sareum
Sareum is a specialist drug growth firm delivering focused small molecule therapeutics to enhance the remedy of autoimmune ailments and most cancers. The Company goals to generate worth by way of licensing its candidates to worldwide pharmaceutical and biotechnology firms on the preclinical or early medical trials stage.
Sareum is advancing inner programmes targeted on distinct twin tyrosine kinase 2 (TYK2) / Janus kinase 1 (JAK1) inhibitors by way of preclinical growth as therapies for autoimmune ailments, together with the ‘cytokine storm’ immune system overreaction to Covid-19 and different viral infections, (SDC-1801) and most cancers immunotherapy (SDC-1802).
Sareum additionally has an financial curiosity in SRA737, a clinical-stage oral, selective Checkpoint kinase 1 (Chk1) inhibitor that targets most cancers cell replication and DNA injury restore mechanisms. Preliminary Phase 2 and complete preclinical information recommend SRA737 could have broad utility together with different oncology and immune-oncology medication in genetically outlined sufferers.
SRA737 was found and initially developed by scientists at The Institute of Cancer Research in collaboration with Sareum, and with funding from Sareum and Cancer Research UK. SRA737 was licensed by CRT Pioneer Fund (CPF) to Sierra Oncology Inc. Sierra continues to discover choices that might allow the event of SRA737 to advance.
Sareum Holdings plc is listed on the AIM market of the London Stock Exchange, buying and selling beneath the ticker SAR. For additional info, please go to the Company’s web site at www.sareum.com
Full yr outcomes for the 12 months ended 30 June 2021
CHAIRMAN’S AND CEO’S STATEMENT
Sareum continues to make progress advancing its proprietary, selective twin tyrosine kinase 2 (“TYK2”) / Janus kinase 1 (“JAK1”) inhibitors, SDC-1801 and SDC-1802, by way of preclinical growth.
We are happy to report that we’re approaching an vital milestone with SDC-1801, the beginning of human medical growth, focusing on autoimmune ailments.
As famous within the Company’s Trading Update of 19 August 2021, we anticipate to finish the toxicology research required for this part of the preclinical programme for SDC-1801 by the top of 2021 and have initiated the method to fabricate drug product for medical trials.
We made the choice to develop a capsule formulation of SDC-1801 for these first-in-human trials relatively than orally dosed options or suspensions, which requires further time, however the Board believes will add worth to the programme and take away the necessity to develop capsules at a later stage.
We have appointed consultants to advise on the design of those medical trials, which can kind a key factor of the exploratory Clinical Trial Application (“CTA”) we intention to file. The submitting of this CTA is now focused for mid-2022 to permit us to finish the mandatory work. The CTA approval is a key step to permit the primary human research with SDC-1801 to start shortly thereafter, topic additionally to drug product provide and extra funding.
In addition, we had been delighted to obtain grant funding from the UK authorities in late 2020 to research SDC-1801 as a possible remedy for the extreme respiratory signs of Covid-19. We have since accomplished the analysis programme and generated encouraging preliminary outcomes. These ends in contaminated lung cells and in vivo illness fashions show that SDC-1801 reduces ranges of key inflammatory brokers identified to play a job within the severe and probably life-threatening hyper-inflammatory response that impacts some Covid-19 sufferers.
We at the moment are contemplating how we’d make use of the UK authorities’s AGILE medical trial platform, or different equal programmes, to offering funding and assist for Phase 1 trials with SDC-1801 for Covid-19 purposes and probably fast-track its growth. The timing and design of those medical trials might be decided following consultations with consultants within the area.
It is obvious that that there’s nonetheless a transparent want for brand new therapies to deal with extreme respiratory irritation arising from viral infections resembling Covid-19 regardless of the success of the UK vaccination programme and the supply of vaccines all over the world. With TYK2 acknowledged as a key therapeutic goal for extreme Covid-19 in an article printed in December 2020 within the main scientific journal, Nature*, we imagine that SDC-1801 might have a job to play on this space sooner or later and we stay up for updating shareholders on additional progress.
Turning to our licensed pipeline, now we have been inspired by occasions occurring at Sierra Oncology, Inc. (“Sierra”) relating to SRA737, a clinical-stage inhibitor of Checkpoint Kinase 1 (“Chk1”), by which Sareum has an financial curiosity.
We imagine that the amended licensing deal between Sierra and CRT Pioneer Fund LP (“CPF”) on SRA737 signed in November 2020 represents a key step in restarting the medical growth of this promising candidate. Further, Sierra famous that SRA737 could have potential together with SRA515, a novel BET inhibitor it in-licensed from AstraZeneca in August 2021 and now anticipates that it might start mixture research together with SRA737 within the first half of 2022. The dosing of the primary affected person with SRA737 in one in every of these medical trials would set off a US$2.0m milestone fee from Sierra, of which Sareum would obtain a 27.5% share equating to roughly $0.55m. We stay up for additional updates from Sierra.
In phrases of enterprise growth, we’re persevering with to maintain potential companions knowledgeable of our progress with a view to securing business licences for our TYK2/JAK1 programmes that stability value and danger with maximising shareholder worth. We will, as common, hold shareholders up to date on this regard as acceptable.
*Pairo-Castineira, E. et al. Genetic mechanisms of crucial sickness in COVID-19. Nature. 2021 Mar;591(7848):92-98. doi: 10.1038/s41586-020-03065-y. Epub 2020 Dec 11.
PROGRAMME UPDATES
SDC-1801 (autoimmune ailments, resembling psoriasis, lupus, inflammatory bowel illness, rheumatoid arthritis, and many others)
Sareum is nearing the completion of preclinical growth with its novel oral TYK2/JAK1 inhibitor SDC-1801 and is conducting the ultimate set of toxicology and security research. Consultants have been appointed to advise on the design of Phase 1 medical trials, and this design will kind a key factor of the exploratory Clinical Trial Application (“CTA”) for SDC-1801.
A sturdy manufacturing route has been developed to provide the SDC-1801 lively ingredient (drug substance) beneath Good Manufacturing Practice (“GMP”) situations, and a specialist Contract Manufacturing Organisation has been appointed to supply GMP drug product for medical trials.
SDC-1801 drug product is being developed as a formulation in capsules, relatively than the orally dosed options or suspensions which might be typically utilized in Phase 1 medical trials. While growth of a capsule-based drug product requires further time at this stage, the Board believes it is going to add worth to the programme by eradicating the necessity to develop capsules at a later stage, making the programme extra engaging to potential growth companions.
The time wanted to provide drug product in capsule kind, mixed with the results of Covid-19 being skilled by a number of of our contracting firms, has meant that CTA submitting is now anticipated in mid-2022. The first medical trials are anticipated to start shortly thereafter, topic to gaining the requisite approval, drug product provide and extra funding. These research would examine the security of SDC-1801 in wholesome volunteers throughout which era the Company will assess the preliminary indications for additional examine.
During the interval, Sareum famous that encouraging information had been reported from preclinical research with its TYK2/JAK1 inhibitors in illness fashions of systemic lupus erythematosus, an autoimmune illness with important unmet want. These research had been performed by Sareum’s co-development accomplice SRI International beneath a US Department of Defense grant and printed on the web site of the Defense Technical Information Center.
SDC-1801 (extreme part Covid-19)
Sareum started its Covid-19 programme with SDC-1801 in December 2020 following the award of a £0.17m grant by UK Research & Innovation (“UKRI”) to research whether or not SDC-1801 can down-regulate or block the TYK2/JAK1-mediated Interferon Type 1 pathway in cells contaminated with SARS-CoV-2. It has been noticed that this pathway is over-active in extreme Covid-19 sufferers and this may result in life-threatening Acute Respiratory Distress Syndrome (“ARDS”).
The six-month challenge was accomplished on schedule, producing promising outcomes. The challenge discovered that SDC-1801 lowered the degrees of cytokines related to ARDS in human lung cells contaminated with SARS-CoV-2 and demonstrated a profile that was superior to the anti-inflammatory steroid dexamethasone and just like baricitinib, a JAK1/JAK2 inhibitor.
Furthermore, outcomes from in-vivo research supported the preliminary mobile outcomes and supply sturdy proof that expression of Type 1 interferons (IFNa and IFNb) is lowered by SDC-1801 remedy in a dose-responsive method.
An enhance in viral load is a possible concern when some anti-inflammatory brokers are used to dampen down an over-active immune response; nonetheless, these research additionally confirmed that viral masses didn’t enhance after SDC-1801 administration, indicating that elevated SARS-CoV-2 virus ranges shouldn’t be a difficulty in any medical research of SDC-1801.
The Company goals to start Phase 1 medical trials for SDC-1801 in mid-2022, topic to profitable completion of the continuing preclinical toxicology research, receipt of GMP drug product, gaining the requisite approval and financing.
The design and timing of the medical trials for Covid-19 purposes might be decided following consultations with consultants within the area. The trial could also be eligible for additional UK authorities funding from the not too long ago launched AGILE medical growth platform, or equal programmes, which have been established to fund Phase 1 trials and fast-track the event of probably ground-breaking Covid-19 therapies.
SDC-1802 (most cancers)
Sareum continues to advance the preclinical growth of an oral formulation of SDC-1802 and has designed and initiated translational research to outline the optimum most cancers utility previous to finishing toxicology and manufacturing research.
Intellectual Property
The Company had two new US patents granted throughout 2021 (in January and September) that reinforce the patent safety for SDC-1802 and its use in treating sure cancers (together with pancreatic, colorectal and kidney cancers, melanoma, and B-cell lymphoma) by inhibiting TYK2 kinase.
Additionally, a patent utility describing various crystalline types of a TYK2 inhibitor for medicinal purposes, filed by Sareum in April 2020, was printed on 14 October 2021. This kind of patent is commonplace pharmaceutical business apply and an vital step to totally shield the mental property surrounding the Company’s analysis programmes and to increase the life span of its patent portfolio.
LICENSED PROGRAMME
SRA737 (most cancers)
SRA737, a potent, extremely selective, orally bioavailable small molecule Chk1 inhibitor, is licensed to Sierra Oncology. SRA737 has proven constructive preliminary security and efficacy information together with low-dose gemcitabine (“LDG”) in a broad Phase 1/2 medical growth programme in stable cancers, significantly anogenital most cancers, in addition to very promising ends in preclinical research together with LDG and an immune checkpoint inhibitor.
Development of SRA737 has been on maintain for the reason that second half of 2019 as Sierra prioritised its assets on the event of its Phase 3 candidate momelotinib. Since then, Sierra has been exploring choices to assist the continued growth of SRA737 and has made a number of disclosures that time to future alternatives for advancing this programme internally.
In November 2020, Sierra and CPF agreed an modification to their authentic 2016 licence settlement (the “Licence Agreement”) that barely reduces the combination excellent milestone funds payable by Sierra from as much as $319.5m to as much as $290.0m. The modification additionally lowered potential near-term funds from Sierra and now features a milestone fee of $2.0m upon the dosing of the primary affected person within the subsequent medical trial of SRA737. Post the modification, Sareum continues to be eligible for 27.5% of the economics of the Licence Agreement.
Encouragingly, in August 2021, Sierra introduced the in-licensing of the BET inhibitor AZD5153 (now referred to as SRA515) from AstraZeneca and famous potential combos with SRA737 as a potential pipeline growth alternative. In September 2021, Sierra offered an replace that referred to the initiation of further medical research with pipeline brokers together with SRA737 in different haematologic and stable tumour indications within the first half of 2022. Specifically, reference was made to a possible position for SRA737 together research in stable tumours, together with pancreatic most cancers, the place sufferers have grow to be proof against PARP inhibitors.
Sareum continues to imagine that, primarily based on preclinical and early medical information, SRA737 holds nice promise for the remedy of most cancers, significantly together settings, and that that the amended licensing settlement and replace relating to SRA515 might expedite the development of the SRA737 programme.
Sareum will present updates on progress as and when Sierra makes additional disclosures in relation to the event of SRA737.
IMPACT OF COVID-19 ON OPERATIONS
Restrictions from the pandemic and knock-on results have impacted on the Company’s community of Contract Research Organisations, with lead occasions growing for brand new experiments. This has triggered some delays to the conduct of a few of the ultimate preclinical research the Company is required to finish with SDC-1801 previous to CTA submitting.
FINANCIAL REVIEW
Sareum ended the complete yr to 30 June 2021 with a sturdy money place following two subscriptions by a high-net-worth person that raised £2.37m earlier than bills in June 2021.
As a consequence, money at financial institution was £2.7m as of 30 June 2021 (£1.3m as at 31 December 2020; £1.8m as at 30 June 2020).
Post period-end (in July and August 2021), the Company raised an extra £2.18m (earlier than bills) by way of share subscriptions by two further excessive web value people plus an train of warrants, bringing the entire raised to roughly £4.6m to fund the additional growth of SDC-1801 and SDC-1802. Cash at financial institution was £4.4m as at 30 September 2021.
The Company additionally obtained an R&D tax credit score of £0.13m in January 2021 and expects to obtain £0.22m in R&D tax credit score in January 2022.
Loss on unusual actions (after taxation) for the yr ended 30 June 2021 was £1.5m (2020: lack of £0.99m), reflecting the elevated R&D expenditure required for preclinical growth.
Salary Deferral Scheme
The Salary Deferral Scheme introduced by the Company on 17 December 2019 and up to date on 1 July 2020 led to August 2021 with a complete of £0.16m, representing all quantities excellent, being settled in money. This follows the numerous c.£4.6m enchancment within the Company’s monetary place arising from the share subscriptions and warrant workouts between June and August.
OUTLOOK
Sareum continues to advance the preclinical growth of its proprietary twin TYK2/JAK1 inhibitor programmes SDC-1801 and SDC-1802, supported by a sturdy money stability following the latest financing occasions.
The preclinical programme for SDC-1801 is sort of full, and an exploratory CTA to achieve approval to start out first-in-human trials is anticipated to be submitted in mid-2022, which might allow first medical trials to start shortly thereafter if the requisite approval, drug product provide and additional funding is secured. Achieving these milestones would mark a big step ahead for the Company.
The Company can also be in discussions across the medical growth of SDC-1801 in Covid-19 and is contemplating the potential of making use of for additional UK authorities funding from the not too long ago introduced AGILE medical growth platform to advance the programme into the clinic.
Regarding SRA737, we proceed to observe Sierra’s actions because it explores medical settings for the longer term growth of this novel compound. We are inspired by the latest disclosures Sierra has made and assured that these will allow the SRA737 programme to advance, with the potential for brand new medical trials together with SRA737 to start out within the first half of 2022. We are following this with nice curiosity and can present additional updates on this programme when info turns into out there.
Overall, we’re wanting ahead with optimism to the rest of 2021 and 2022, throughout which era we anticipate to report on continued progress with our proprietary programmes, specifically the development of SDC-1801 into the clinic.
In addition, we proceed to deploy our funds to advance our TYK2/JAK1 programmes and construct a sturdy information package deal to assist ongoing partnering actions for these differentiated property. For each TYK2/JAK1 inhibitor programmes, the Directors will proceed to evaluation the potential increased worth of a later-stage licensing deal versus the requirement for any further funding.
The Board and administration proceed to make use of rigorous capital allocation within the growth of inner property and the general enterprise, with a transparent give attention to producing worth for shareholders.
We wish to thank our shareholders, suppliers, contractors and different stakeholders for his or her continued assist and stay up for offering additional updates on progress as we transfer ahead in 2021 and 2022.
Dr Stephen Parker Dr Tim Mitchell
Chairman Chief Executive Officer
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